DIASTAT TOTAL ANTI-CARDIOLIPIN KIT

FDA 510(k)

FDA Class 2 ·Immunology

SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200

FDA 510(k)

FDA Class 2 ·Hematology

ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS

FDA 510(k)

FDA Class 2 ·Immunology

KONICA DIRECT DIGITIZER REGIUS MODEL 330

FDA 510(k)

FDA Class 2 ·Radiology

Magseed Magnetic Marker System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

TEVES ECM (ENDOTRACHEAL CARDIAC MONITOR)

FDA 510(k)

FDA Class 2 ·Anesthesiology

DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T

FDA 510(k)

FDA Class 2 ·Immunology

MANGAR BOOSTER

FDA 510(k)

FDA Class 2 ·General Hospital

CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

CS 1600 INTRAORAL CAMERA

FDA 510(k)

FDA Class 2 ·Dental

MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR

FDA 510(k)

FDA Class 2 ·Neurology

CARRIGEN

FDA 510(k)

FDA Class 2 ·Orthopedic

GAMMA-BSM, BETA-BSM

FDA 510(k)

FDA Class 2 ·Orthopedic

THE FUGO BLADE

FDA 510(k)

FDA Class 2 ·Ophthalmic

ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE

FDA 510(k)

FDA Class 2 ·Orthopedic

ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE

FDA 510(k)

FDA Class 2 ·Dental

THE FUGO BLADE FOR GLAUCOMA

FDA 510(k)

FDA Class 2 ·Ophthalmic